Our facility has undergone hundreds of successful client audits as well as comprehensive inspections by regulatory agencies.

• FDA performed two audits (2003, 2004) with no 483s issued
• MHRA performed three inspections (2003, 2005, 2008) resulting in letters/certificate of compliance
  

We believe that compliance must be practiced individually before it can be achieved corporately. This belief has empowered our personnel to take an active role in establishing and maintaining critical compliance programs.

Our quality systems are designed to support manufacturing, product release testing, and product stability programs. This quality system consists of three key programs:

• Documentation control: this program consists of master controlled documents with restricted access
• Validation: these programs are designed to cover our facility, equipment, processes and supplier audits
  
• Personnel training: our training programs include cGMP, task-specific, and safety training

To request more information on our aseptic fill and finish capabilities, please click here.  

Case Study – Increase Bioavailability

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Case Study – Formulation/Dosage Form Change

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Case Study – Analytical Development